Search by Drug Name or NDC

    NDC 00078-0681-66 Tafinlar 75 mg/1 Details

    Tafinlar 75 mg/1

    Tafinlar is a ORAL CAPSULE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Novartis Pharmaceuticals Corporation. The primary component is DABRAFENIB MESYLATE.

    Product Information

    NDC 00078-0681
    Product ID 0078-0681_23689dc5-f2a5-4475-bbc1-bd73107e51ba
    Associated GPIs 21532025100130
    GCN Sequence Number 071034
    GCN Sequence Number Description dabrafenib mesylate CAPSULE 75 MG ORAL
    HIC3 V37
    HIC3 Description ANTINEOPLASTIC - BRAF KINASE INHIBITORS
    GCN 34724
    HICL Sequence Number 040360
    HICL Sequence Number Description DABRAFENIB MESYLATE
    Brand/Generic Brand
    Proprietary Name Tafinlar
    Proprietary Name Suffix n/a
    Non-Proprietary Name dabrafenib
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form CAPSULE
    Route ORAL
    Active Ingredient Strength 75
    Active Ingredient Units mg/1
    Substance Name DABRAFENIB MESYLATE
    Labeler Name Novartis Pharmaceuticals Corporation
    Pharmaceutical Class Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C8 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA], Kinase Inhibitor [EPC],
    DEA Schedule n/a
    Marketing Category NDA
    Application Number NDA202806
    Listing Certified Through 2024-12-31

    Package

    NDC 00078-0681-66 (00078068166)

    NDC Package Code 0078-0681-66
    Billing NDC 00078068166
    Package 120 CAPSULE in 1 BOTTLE (0078-0681-66)
    Marketing Start Date 2016-04-01
    NDC Exclude Flag N
    Pricing Information N/A